BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Primo Dental Laser

    Reg #: 3030090167 · FEI: 3030090167 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    MEDENCY SRL
    Registration Number
    3030090167
    FEI Number
    3030090167
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via degli Ontani, 48 - Vicenza (Italy)
    City
    Vicenza Veneto
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K232222

    Owner / Operator

    Firm Name
    Medency Srl
    Operator Number
    10089308
    Address
    Via degli Ontani, 48 - Vicenza (Italy)
    City
    Vicenza
    State
    IT-VI
    Postal Code
    36100
    Country
    IT
    Correspondent
    Alessandro Boschi

    US Agent

    Business Name
    Carrasco
    Contact Name
    Mateo Carrasco
    Address
    1815 Barker Drive Winter Park, Florida, 32789, UNITED STATES
    City
    Winter Park
    State
    FL
    ZIP
    32789
    Country
    US
    Email
    [email protected]
    Phone
    407 2849480

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Laser, Dental, Soft Tissue NVK

    Proprietary Names

    Primo Dental Laser

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device